[Also posted on Postscript]

The guilty plea and $1.5 billion settlement by Abbott to resolve their illegal off-label promotion of Depakote revealed a saga of extensive industry abuses and influence peddling that put millions of vulnerable seniors at risk. Abbott’s extensive promotion of the unapproved uses of the anti-convulsant drug Depakote to treat both seniors with dementia and to treat children is shocking. But it is even more alarming that this not the first major drugmaker to plead guilty to illegal marketing tactics that have targeted this exceptionally vulnerable population of seniors.

Many may recall that Eli Lilly was caught illegally promoting the unapproved, or “off-label” use of the antipsychotic drug Zyprexa to treat seniors with dementia, despite their internal studies showing that the risk of death from this drug increased in elderly patients.

Marketing these drugs to nursing homes for use on patients who ‘act up’ or are unruly has been a lucrative strategy for drugmakers. In response, we applaud the Department of Justice and the State Attorneys-General for their increasingly aggressive litigation to penalize these dangerous and unconscionable marketing practices.

But unfortunately for the millions of seniors who may be given Depakote or Zyprexa today or in the near future, the record-breaking $1.4 and $1.5 billion settlements respectively may not translate into improved care, unless further action is taken.

We urge Medicare and Medicaid officials at the federal and state level to move quickly to develop and implement safeguards, such as prior approvals or mandatory second opinions, that could be put in place to protect these vulnerable seniors from any unwarranted or inappropriate use of the drug Depakote to treat their dementia.

Looking forward, it’s time that all off-label settlements by the DOJ or the states include a requirement that the drugmaker pay to correct the misinformation that off-label marketing creates – i.e. that a drug is safer or more effective than it really is. Using lawsuits to fund corrective educational campaigns has a long history, both in public and private sector litigation. (See description here.)

To help stop the inappropriate and potentially harmful overuse of Depakote, Zyprexa, or Risperdal from continuing, doctors should be retrained to undo the misinformation campaigns by Abbott, Eli Lilly, and Johnson and Johnson. Several states, including Pennsylvania and New York have implemented “academic detailing” programs that send independent medical experts, usually nurse practitioners and pharmacists, to provide doctors with the truth about how effective drugs are from an objective, evidence-based perspective. Many state programs specifically address mental health drugs such as Zyprexa and Depakote. Indeed, one of the first of these education programs designed by Dr. Jerry Avorn, who spearheaded the concept in the 1990’s, recommended that a little tender loving care by nursing home staff could reduce the inappropriate use of sedatives, common at that time. A similar conclusion was reached by some nursing homes profiled in an  inspiring Boston Globe article addressing the overuse of Depakote.

– Wells Wilkinson,
Director, Prescription Access Litigation
Staff Attorney, Community Catalyst

Today, the 1st Circuit Court of Appeals issued a decision in IMS v. Ayotte, the case challenging New Hampshire’s Prescription Confidentiality Act, which prohibits the commercial use of prescriber data, including for pharmaceutical detailing. The Court unanimously upheld the law, finding that it did not violate the First Amendment. The opinion weighed in at a hefty 148 pages.

The Act sought to prohibit the practice of “datamining” for the purpose of pharmaceutical marketing: pharmacies sell doctors’ individual prescribing data (what drugs the doctors prescribed, when, and how often) to companies that aggregate such data. Those companies then sell prescribing “profiles” of individual physicians to drug companies, whose salespeople can then use that information to tailor the “pitch” that they use in marketing their drugs to those doctors. For instance, if a doctor has been prescribing a competitor’s drug, they might tailor the sales pitch to talk about why their drug is allegedly superior.

IMS Health, a company that collects and sells pharmacy data on doctors’ prescribing practices, sued the state of New Hampshire before the ink was barely dry on the law. They alleged that it violated their First Amendment rights. In April 2007, the U.S. District Court for the District of New Hampshire agreed, and struck down the law. The State of New Hampshire appealed the decision to the 1st Circuit Court of Appeals, which heard the appeal in January 2008.

Sean Fiil-Flynn, who represented PAL’s parent organization Community Catalyst, as well as AARP, National Legislative Association on Prescription Drug Prices, National Physicians Alliance, New Hampshire Medical Society, and Prescription Policy Choices in filing an amicus brief before the 1st Circuit, gave an excellent analysis of the decision and its ramifications:

The court unanimously upheld the New Hampshire law. The majority found that the act does not regulate speech, but rather regulates only the conduct of health information companies that aggregate and sell prescription records. The concurrence concluded that the Act does affect speech of pharmaceutical marketers, but the regulation is nonetheless justified by the state’s overriding interest in promoting cost containment in the pharmaceutical sector.

This is an important decision for data privacy advocates. The ramifications of giving companies a First Amendment right to sell data on all of our purchases, travel and activities would be staggering. The First Circuit ruled on the side of consumer privacy, admonishing that the First Amendment does not protect every exchange of information from traditional social and economic regulation. It refused to apply the First Amendment to the trading of prescription records for marketing purposes where “information itself has become a commodity.” The court explained that applying the First Amendment to such trade in prescription data “stretches the fabric of the First Amendment beyond any rational measure.”

The 148 pages of analysis exhaustively analyses the voluminous evidence amassed by New Hampshire demonstrating the negative effects on our health care system of allowing pharmaceutical marketers to use prescription record tracking to target their marketing efforts.

The court affirmed that states have a valid interest in regulating the use of prescription records to target marketing to doctors. The court found that the use of such information to identify doctors who prescribe lower cost drugs and target marketing campaigns at them has a demonstrable impact on pharmaceutical spending that states are not disempowered to respond to. Access to individualized prescription data also allows companies to target gifts, consultancies and other perks to their most favored physicians, in effect incorporating prescribers into the commission structure of their sales forces. These practices debase the medical profession and, the more the practices become public, break the chain of trust between doctor and patient.

Other resources:

• The 1st Circuit’s decision is here
• An Associated Press article on the decision is here: NH prescription privacy law upheld
• The 1st Circuit Amicus Curiae brief of Community Catalyst and others is here.
• The District Court Amicus Curiae brief of Prescription Access Litigation and others is here.
• See also what PostScript, the blog of our colleagues at The Prescription Project, had to say about the decision.

The National Coalition for Appropriate Prescribing (led by the Prescription Project - a sister organization to us here at Prescription Access Litigation) is working to pass the Physician Payments Sunshine Act, a transparency bill requiring pharmaceutical companies to publicly report their gifts and payments to doctors. The Senate version of the bill is
here and the House version is here.

Pharmaceutical and medical device industry marketing to doctors (well over $30 billion each year) takes the form of gifts, honoraria and other payments. This spending subtly and not-so-subtly induces doctors to prescribe newer and more expensive treatments, regardless of whether they’re better. This in turn drives up drug costs and puts patients at risk, because new and heavily marketed drugs are almost always more expensive, even though they are often no more effective than older, established therapies. Newer drugs may also have unknown side effects.

We believe the public deserves to know how much money individual physicians are accepting from industry. (Disclosure laws in Minnesota and Vermont reveal that many doctors receive industry payments of thousands or tens of thousands of dollars a year.) The Sunshine Act will benefit patients, payers, policy makers and taxpayers alike by creating transparency.

Key provisions include:

• Comprehensive and publicly available reporting of information down to the individual prescriber level;
• A low ($25) threshold for reporting; inclusion of all payments; and
• penalties for companies that don’t report.

Sign this petition today to ask your members of Congress to support these bills: http://www.thepetitionsite.com/1/sunshine

For more information:

• To learn more about industry payments to doctors click here
• For factsheets on the Sunshine Act House and Senate bills click here
• To see the organizations that are members of the National Coalition for Appropriate Prescribing click here

Sign the petition

Over at A Healthy Blog, our friends at Health Care For All (a member of the Prescription Access Litigation coalition) report today on the fight that is brewing in the Massachusetts legislature over a proposed ban on pharma gifts to physicians. They quote an article from yesterday’s State House News Service:

Pharmaceutical companies are attacking Senate President Therese Murray’s effort to block their firms from providing gifts, meals or trips to doctors, calling it an anti-business policy that would hobble efforts to deliver cutting-edge drugs to patients. In a letter to the chairs of the Legislature’s Economic Development and Emerging Technologies Committee, executives from Pfizer, Amgen, Abbot Bioresearch Center, Genentech, all of which have facilities in Massachusetts, ripped the gift ban as counter to Beacon Hill’s painstaking efforts to lure the life sciences industry, highlighted by Gov. Deval Patrick’s nearly year-old $1 billion incentives plan headed for legislative approval.

It’s somewhat odd to cast a gifts and lunches to doctors as being on par with a $1 billion state incentive plan — unless perhaps the gifts and trips and meals are worth more than $1 billion to the industry — after all, Massachusetts has dozens of teaching hospitals and a new health care law that means more and more people with health insurance. The prescriptions written as a result of a modest investment in gifts and trips and meals could easily garner more than a billion in new sales.

To learn more about the proposed gift ban, go visit the Massachusetts Prescription Reform Coalition.

CalPIRG, a member of Prescription Access Litigation’s coalition, released a new report last week, titled “Playing By Their Own Rules: An Analysis of Drug Company Gifts to Doctors”. As CALPIRG’s announcement describes:

CALPIRG released a new analysis today examining drug companies’ self-imposed limits on their marketing to doctors – efforts that include lavish wining-and-dining and thousands of dollars worth of gifts. The report, Playing By Their Own Rules: An Analysis of Drug Company Gifts to Doctors, finds that these limits are riddled with exceptions, and that some companies have evaded even the least restrictive limits on their marketing.

“Patients need to know that prescriptions are being written on the basis of science, not high-priced meals and upscale gifts,” said Michael Russo, Health Care Advocate with CALPIRG. “Strong limits on these marketing efforts are necessary to protect patients – and our research shows that the limits the drug companies have chosen for themselves amount to no limits at all.”

Drug company marketing showers doctors with fancy dinners and costly giveaways, aimed at convincing them to prescribe the latest, most expensive, least-tested drugs – forcing patients to pay top dollar, and subjecting them to potentially unknown side effects. Current California law requires drug companies to choose, and then abide by, dollar limits on the value of gifts and free meals they give to doctors as part of their marketing efforts.

But CALPIRG’s analysis shows that these “limits” often allow the companies to give as much as they wish. Key findings include:

• Drug companies fail to count some meals and other payments as “gifts,” and therefore they are not subject to the limit;
• Some companies reserve the right to exceed their limits if they so choose;
• Others assert that they are following a limit, but do not disclose what that limit actually is, while a few fail even to post their policies at all;
• Since 2005, 5 of the largest companies have raised their limits, by an average of $1,100 dollars per doctor per year.

“It’s disappointing that the drug industry hasn’t even been able to comply with their own rules,” said Russo. “We’ve let the foxes guard the henhouse long enough.”

When drug company marketing succeeds, it induces doctors to over-prescribe the newest, priciest drugs, inflating the cost of prescription drugs. Also, because the newest drugs have been on the market for the least time, they may have potentially unknown side effects.

“By playing by their own rules, the drug companies have let themselves get away with whatever they want,” said Russo. “It’s time we set a hard, enforceable limit on doctor gifts, and require those gifts to be publicly disclosed. Patients need to have confidence that when a doctor decides which drug to prescribe, drug company marketing isn’t part of the equation.”

CALPIRG’s analysis shows that some companies by all appearances are not complying with California law governing drug company marketing to doctors. “We urge the Attorney General to investigate our findings, and take appropriate action to make sure these companies follow the law,” said Russo.

The Boston Globe today ran “A line between docs and drugs,” an editorial that featured our colleagues at the Prescription Project. The editorial lauded academic medical centers that are implementing policies restricting the “freebies” and other marketing thrown their way in drug company attempts to influence their prescribing. Kudos to the Prescription Project for helping usher in these changes and to the Boston Globe for highlighting this growing trend!

A line between docs and drugs
February 25, 2008

Third in a series
PRESCRIPTION drug companies develop, manufacture, and sell powerful medicines. Academic medical centers treat patients and train physicians. Both the drug industry and the teaching hospitals play essential roles in modern medicine, but their functions need to be kept separate, as they will be under a policy recently unveiled by UMass Memorial Medical Center in Worcester.

Health insurance companies and state governments have encouraged physicians to prescribe generic products, and the rate of prescription drug inflation has diminished significantly. But keeping inflation down is a constant battle in healthcare. Academic medical centers, as shapers of physician opinion, ought to lead the way in protecting physician education from marketing by drug companies and their companion industry, the manufacturers of medical devices.

The UMass Memorial policy, up for final approval Wednesday, would prohibit hospital physicians from receiving gifts or meals from drug companies. Doctors wouldn’t be able to accept drug samples, which would instead be distributed by the central pharmacy. Donations to physicians for educational programs would be banned. Companies could contribute to a hospital fund for education or direct money to a department, but administrators would determine the content of the program.

This policy goes against a tradition of drug company largesse, but hospitals around the country are realizing that they can no longer serve as marketing adjuncts. In Massachusetts, a nonprofit coalition under the umbrella of the Prescription Project is shaping opinion to a strict standard. Last summer, Boston Medical Center adopted a policy similar to UMass’s, although physicians can partake of free food off campus if they “use discretion.”

Elsewhere in Boston, Tufts-New England Medical Center bans gifts, and, assisted by the Prescription Project, is working on a comprehensive policy. The Partners network imposes restrictions, but many can be waived by a department chief. Drug companies can offer informational meetings, with a meal if the food costs less than $20 per person and the chief approves. Samples can be accepted, if the program or department allows them, as can gifts worth less than $100. At Beth Israel Deaconess, a company can pay for food at seminars as long as the department approves. Doctors can get samples (for poor patients), and gifts, too, up to an annual $300 limit.

Partners, at least, is working on a tougher policy. Dr. Daniel Podolsky, its chief academic officer, cautioned, “We want doctors to know what is the best state-of-the-art care.” Drug and devices companies spend billions of dollars on marketing, and they’ll get their message out one way or the other. Hospitals need to make sure the information is not tainted by even a tiny bit of physician self-interest.

There’s a bevy of opinion pieces and articles about drug marketing in the news today, mostly in the wake of the “Jarvik-row-gate,” the scandal concerning Dr. Robert Jarvik, Lipitor pitchman, being neither a licensed physician nor a practicing rower. We blogged on this story here and here.

Here’s a roundup, saving you the time of actually having to go read these pieces yourself. We aim to please here at the PAL blog.

In the Chicago Tribune today, Katie Watson, acting associate director of the medical humanities and bioethics program at Northwestern University’s Feinberg School of Medicine, opines about “a terrible disease — physician addiction to drug money.” She cautions against overfocusing on Dr. Jarvik and his lack of prescribing and rowing credentials, and recommends instead that “Congress should use his Lipitor endorsement as a catalyst for reviewing the larger issues it raises.”

She raises a point that we here at PAL and others have made in the past: That pharmaceutical advertising, nay, medical advertising in general, improperly turns “patients” into “consumers:”

Pharmaceutical advertising is a good place to start. This is typically called “direct-to-consumer” advertising, and the committee’s letter to Pfizer says it’s concerned that “consumers” may misinterpret Jarvik’s health claims. But consumers can’t buy prescription drugs, only patients can. Patients are people who make decisions with expert partners; consumers roam grocery stores picking cereal alone. Once patients were recast as consumers, prescription drugs could be advertised as if they were tennis shoes. It was just a matter of time before a celebrity pitchman turned a drug like Lipitor into Air Jarvik.

The pharmaceutical industry uses advertising to pull patients away from physicians — come in with your mind made up, and your physician is reduced to prescription writer. The industry undermines the other side of the patient-physician partnership by throwing money at physicians. This half of the divide-and-conquer strategy usually happens behind the scenes, but Pfizer’s partnership with Jarvik for mutual profit makes a widespread practice visible.

Business Week hosts a “debate” on the topic of “Halt the Pharma Freebies.” On the “Pro” side to ending pharma trips, meals and gifts is Dr. Philip A. Pizzo, from Stanford University Medical Center. He recounts Stanford’s adoption of policies in 2006 seriously restricting pharma access to doctors in the hospital:

In October, 2006, we enacted a policy across the Stanford University Medical Center campus, prohibiting our faculty members from accepting gifts of any kind, however small, anywhere on the medical campus or at off-site facilities where they may practice.

It also bars industry sales and marketing representatives from wandering the hallways of our two hospitals and our laboratories, and prevents companies from directly paying for meals in connection with educational programs—once a fairly common practice. It requires that those involved in the decision to buy formulary drugs or clinical equipment disclose any related financial interests….

Since our policy went into effect, many other academic medical centers have followed suit. As we train the next generation of physicians under these new standards, we will sow the seed for what could be a wholesale cultural change in the U.S. medical profession.

Our colleagues at The Prescription Project are working with numerous other academic medical centers to adopt policies similar to Stanford’s. They author the very fine blog, PostScript.

On the “Con” side is Ken Johnson, from PhRMA, who has the unenviable task of defending his industry’s positions. Unfortunately, his arguments fail to stray from the now-very-tired PhRMA playbook, and fly in the face of quite a bit of documented evidence.

So, despite what critics say, it’s insulting to suggest that doctors would prescribe treatments based on who gave them a slice of pizza, a pen, or a medical dictionary.

It might be insulting, but it doesn’t make it not true. Numerous studies document that even small gifts affect prescribing. (See, e.g. Physicians and the Pharmaceutical Industry- Is a Gift Ever Just a Gift? in JAMA from 2000. See also here for many more studies documenting this.) This is not a conscious quid pro quo (“Gee, that pizza the drug rep brought sure was good. I think I’ll prescribe her drug to the next patient I see.”) but rather a subconscious engendering of good feeling and goodwill. We are all prone to it, whether we went to medical school or not.

What’s more, there are regulations and a comprehensive industry ethics code to help make sure information about new treatments provided by America’s pharmaceutical research companies is accurate and well-substantiated.

To which I can only say, Ha. One need only browse the boards at CafePharma to read numerous tales of the thwarting, skirting and even outright ignoring of said regulations and codes of ethics.

Existing federal law is very clear: Pharmaceutical research companies and their technically trained representatives, including some health-care professionals, must not give physicians anything of value in exchange for the doctors writing prescriptions for their medicines. The companies must also ensure that information they convey to physicians is consistent with pharmaceutical product labeling approved by the Food & Drug Administration. The fact is, federal and state authorities, including the FDA, the Justice Dept., and state Attorneys General are closely monitoring for improper activities.

And guess what? That monitoring, and the work of brave qui tam whistleblowers, has brought to light countless examples of widespread improper activities in the past few years. Which suggests that perhaps, methinks, compliance is not fully robust.

For its part, the Pharmaceutical Research & Manufacturers of America (PhRMA) sponsors ethical guidelines to keep communications between its member companies and physicians focused on proper use of medicines and the needs of patients. The PhRMA ethics code says all forms of entertainment are inappropriate and only modest meals—such as sandwiches—should be provided when doctors meet with pharmaceutical research companies. Additionally, our code says items given to physicians should not exceed $100 in value and should be things, including stethoscopes and medical dictionaries, that benefit patients or support a medical practice.

Ah, voluntary guidelines, the pharmaceutical industry’s favored method to forestall true regulation and enforcement. These guidelines are not binding (except in California, which by legislation adopted them as state law), and there’s no enforcement for violations. PhRMA and their members liked these unenforceable physician gift guidelines so much that they used the same approach for drug advertising in their “”Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines.” These guidelines earned PhRMA one of PAL’s coveted “Bitter Pill Awards” in 2006: The Fox Guarding the Henhouse Award: For Pushing Toothless “Guiding Principles” on Drug Advertising.

In the end, it’s clear pharmaceutical research companies have the most extensive information about new medicines. After all, they devote 10 to 15 years and spend nearly $1 billion to develop just one new medicine in a process that generates thousands of pages of scientific data.

They also have the greatest incentive to “spin” their drugs, by withholding negative information and clinical trial results (ahem, Zetia/Vytorin anyone?), by pushing on doctors medical journal articles that show their drug only in the most favorable light, etc. And PhRMA, please stop trotting out the tired $1 billion figure for new drug development. Merrill Goozner handily refuted that myth in his book The $800 Million Pill (back when PhRMA was only claiming it cost $800M for a new drug) and continues to do so on his excellent blog GoozNews.

Over at HOI-19 News (an ABC affiliate), there’s a story called “Drug Pitch Police.” It begins by reciting, mostly unquestioningly, PHrMA’s claims about drug marketing and the costs of drug development, but then gives a description of the Independent Drug Information Service (IDIS), a program that is providing “counter-detailing” or “academic detailing” to physicians in Pennsylvania. These “academic detailers,” mostly nurses and pharmacists, provide a vital counterbalance to the self-serving and slanted messages of the drug company sales reps. They provide doctors in PA with information about the true effectiveness and cost-effectiveness of various drugs, in order to both reduce costs to Pennsylvania’s Medicaid program and improve treatment.

The Roanoke Times has an editorial today calling on Congress to “Pull the Plug on Drug Ads.” It talks about the House Committee on Energy and Commerce looking into Dr. Jarvik’s bona fides and says, among other things:

The committee is compiling information and will most likely head on down the rabbit hole of “celebrity endorsements.” Instead, it ought to be looking at the bigger picture: It is unwise to allow pharmaceutical companies to continue direct marketing to consumers whether they feature Jarvik or a next-door neighbor…The House committee should be persuaded to go much further than looking at deceptive marketing and, instead, renew the ban on marketing to consumers.”

That’s it, folks, a busy day for those holding forth on drug marketing. What do you think? Good points? Bad points? Beside the point? Let us know in the comments.

In 2006, New Hampshire became the first state to prohibit pharmacies from selling information about what drugs doctors prescribe. Pharmacies routinely collect and sell information on what drugs individual doctors write prescriptions for, and sell it to companies like IMS Health and Verispan. Those companies then sell that data to drug companies. Drug company salespeople use that information to tailor the sales pitch that they make to doctors during visits to doctors’ offices. IMS Health sued the state of New Hampshire, arguing that the new law violated the company’s “free speech” rights.

Prescription Access Litigation’s parent organization, Community Catalyst joined AARP, AFL-CIO, AFSCME, Center for Medical Consumers, Community Catalyst, National Women’s Health Network, and New Hampshire Citizens Alliance in submitting a “friend of the Court” (amicus curiae) brief in support of the law. Unfortunately, the U.S. District Court for the District of New Hampshire struck down the law. The state of New Hampshire appealed, and last week, there was a hearing at the U.S. Court of Appeals for the First Circuit, in Boston, MA.

Sean Flynn, Associate Director of the Program on Intellectual Property at Washington College of Law at American University, was there and argued on behalf of a number of “amici curiae.” Sean reports on that hearing, in the PAL Blog’s first-ever “guest blogger” post. Here’s his dispatch from the hearing:

___________________________________________

On Wednesday, the First Circuit heard arguments in IMS v. Ayotte, involving New Hampshire’s appeal of a district court ruling striking down a first-in-the-nation law prohibiting prescription data mining.

Prescription data mining occurs through “health information companies” like IMS purchasing information from pharmacies on what drugs were prescribed by whom. This information, which is provided without the consent of either the doctor or the patient, is sold to pharmaceutical companies who use it to tailor the marketing of drugs to physicians. Using prescription information identifying prescribers enables drug companies to send a salesperson into a doctor’s office with an individually tailored pitch as well as to identify and reward their best prescribers with gifts, paid consultancies, prestigious board appointments, expense paid “educational” trips and other perks.

According to some estimates, drug companies spend as much as $34 billion a year marketing to doctors. Evidence in the case showed that the average physician sees at least five drug company reps a day.

In 2006, New Hampshire became the first state to outlaw prescription data mining for marketing, and was immediately challenged in court by the major drug information companies. Last May, the law was overturned by the a U.S. District Court, which agreed with the companies that the law violated the First Amendment guarantee of free speech because it “limits both the use and disclosure of prescriber-identifiable data for commercial purposes.”

At the hearing before the First Circuit on Wednesday, the judges appeared very critical of the data mining industry’s assertion that collecting and selling prescription records amounted to protected speech under the First Amendment. Judge Selya, who wrote an important opinion holding that advertising consulting services between companies are not 1st Amendment speech, asked the New Hampshire attorney “if there is any effect on commercial speech, isn’t it just incidental?”

All of the Judge’s questions were focused on the degree to which states can regulate economic conduct with an ‘incidental effect’ on commercial speech rather than whether the law itself was narrowly tailored. The court never asked either side for detailed arguments on whether the law was ‘narrowly tailored’ to meet its objectives, a possible indication that they believe that the law does not regulate protected speech.

The judges were much more critical of IMS’s argument. Judge Lipez asked skeptically whether NH had to have a “Turner record” (three years of congressional hearings used to justify regulating cable speech) for this law. The IMS attorney seemed not to take the hint, responding that NH needed more because this law was akin to regulating the core of the 1st Amendment and therefore required strict scrutiny.

I gave the rebuttal argument on behalf of the public interest amici in the case. The core of my argument was that the First Amendment’s commercial speech doctrine is about protecting the rights of companies to speak to consumers about their products. It does not protect any right of companies to monitor their consumers to see whether their pitches are successful. This law, like many others, regulates the latter by cutting off access to identifying information rather than regulating the substance of what marketers say. It is thus similar in particulars to

• Driver Privacy Protection Act (upheld by Reno v. Condon)

• Video Privacy Protection Act (video rental information)

• Stored Communications Act (internet)

• Electronic Communications Privacy Act

• Fair Credit Reporting Act (upheld by Trans Union v. FTC)

The DPPA is particularly relevant since that law was passed in part to cut down on harassing sales tactics by lawyers searching accident records for potential clients.

We argued that a gift ban would not meet the state’s interests because the monitoring of prescriptions is used to target a host of reinforcements of favored prescribing behavior — including consultancies, educational seminar invitations, prestigious board appointments and even targeted expressions of appreciation — that are difficult or impossible to regulate under gift bans.

I am optimistic about the chances for a favorable ruling. If the First Circuit overturns the ruling striking down New Hampshire’s first in the nation law regulating prescription data mining, several states and the District of Columbia are expected to quickly enact similar laws. Washington State and New York look primed to move soon, possibly without waiting for the ruling. The First Circuit’s ruling will also affect current litigation in Vermont and Maine that passed data mining restrictions soon after New Hampshire.

A recent and welcome addition to the pharmaceutical blogosphere is PostScript, the blog of The Prescription Project (a sister project of Community Catalyst, which is PAL’s parent organization). PostScript has been featuring a series of fascinating interviews with various medical professionals, on the topic of medical ethics and interactions with the pharmaceutical industry. The latest is “How Hooked Happened: a conversation with Howard Brody, M.D.” Dr. Brody is author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Have a look. Here’s a good quote from that interview. I’ve bolded the particularly juicy parts:

Reform has to be a two-pronged thing. First, a professional level of reform: individual physicians growing a certain underdeveloped piece of anatomy….we need our professional spines to be strengthened. And the second piece is regulatory reform: We need to take back medical research from the pharmaceutical industry. There’s got to be some accounting for the bennies [ed: benefits, that is] that these contract research organizations and investigators get from the drug companies.

The public simply cannot demand further tax cuts unless they confront the fact that they are selling medical integrity to the hands of private industry. I think that means we are going to have to pay so that science remains a public good, and not property of the commercial outfits.

In the past several months, WCVB in Boston has run two reports on insurers giving financial incentives to doctors to switch patients off the expensive brand-name cholesterol drug Lipitor (made by Pfizer [NYSE:PFE] and on to a cheaper drug, either generic or brand-name. The most recent was earlier this week: “Doctors May Not Reveal Full Truth Behind Rx Switch.” The tone of the pieces has been one of shock and disbelief, that doctors are receiving some form of payment for making these switches. These reports tell about 1/5 of the real story.

The first key fact, mentioned in passing in the story, is that most patients that need a statin don’t need Lipitor – Lipitor is the “most powerful” statin available, but as one Doctor in the story says, “the vast majority of patients you can get to goal [i.e. get to the desired cholesterol level] with Simvastatin [a generic which used to go by the brand name Zocor] and if you can get them to goal for less money, less money to society, less money to them out of pocket, that’s what we should do.” And with drugs like statins, “more powerful” is not necessarily better — but it is more expensive. If patients’ cholesterol can be lowered to the needed level with a generic, then it should be.

But what about the “payments” to doctors? The story claims that insurers are paying doctors to switch their patients — the story is noticeably silent on the details of these payments:

Many doctors get a financial benefit from insurers through a complicated formula if they switch enough patients off of brand names to generics. Patients see that they are saving money on co-pays, but do they know their physicians are making money?

The choice of phrase “complicated formula” suggests that it’s not a straight payment — i.e. switch a patient, get a check. If it were such a one to one transaction, you can be sure that the story would have made strong emphasis of that fact. So, if, as it seems, the payment is more indirect — i.e. the number of patients that a doctor switches off of Lipitor is part of a larger reimbursement formula, then is there a problem with giving doctors an incentive, even a financial one?

Maybe, maybe not. But let’s put it in context. There are numerous “incentives” pushing doctors to prescribe particular drugs. Let’s look at those incentives and ask where they really stack up:

• 100,000 drug salespeople who work for drug companies like Pfizer (maker of Lipitor) descend on doctors’ offices every day, delivering slick sales pitches on why they should prescribe their patients the most expensive brand-name drugs instead of cheaper and equally effective generics.
• These same drug salespeople come bearing pens, prescription pads, and other gadgets emblazoned with the drug’s name and logo, along with drug samples, lunches for the entire staff, invitations to meals at fancy restaurants where there will be a presentation about the wonders of their drug, and of course a healthy dose of flattery.
• These sales reps enter the office with data purchased from local pharmacies, so they know exactly how many prescriptions the doctor is writing for their drug versus their competitors, and how that rate has changed since the last visit the salesperson made — allowing them to tailor their pitch to that doctor.
• When the doctor opens up the pages of medical journals, they see them plastered with ads for the drugs the salespeople are hawking.
• The doctor may then attend a Continuing Medical Education seminars (a certain number of which doctor must attend each year to keep their license to practice) where the speaker is a paid consultant of the company.
• Doctors who are high-prescribers of the drug or well-known in their region are designated as “thought leaders” and may be invited to be a consultant or part of a “speakers’ bureau” for the company, receiving a payment in return.

And so on, and so on.

As you can see, there are many “incentives” that drug companies give to doctors to get them to prescribe a certain drug over another. Some of them are financial — some are not. But they all influence the doctors’ choice of what drug to prescribe — and more often than not, it influences them to prescribe a newer, more expensive drug, regardless of whether that drug is more expensive or not. These tactics work, otherwise drug companies would not spend more than $20 Billion a year marketing to doctors.

And let’s not forget that drug companies have enlisted us, the consumer, as an unpaid member of their sales force. The pharmaceutical industry spent around $5 Billion on “direct to consumer” drug ads in 2006. Lipitor, the best selling drug in the U.S. and the world, spent $138.2 Million on Lipitor ads in 2006 (see our post, “Top 3 Bestselling Drugs spent $460.5 Million on Ads in 2006″), most of them featuring Dr. Robert Jarvik, inventor of the artificial heart, waxing ecstatic about Lipitor. After the sales rep has visited, and the doctor has seen the ads in the medical journal, and attended the dinner at the fancy restaurant, and gone to the seminar where a colleague who’s on the drug company’s payroll has preached the wonders of the drug, into the office comes the consumer, who says they saw an ad for Lipitor on TV, and that’s the drug they want.

So into this tangled web of pharmaceutical company influence and incentives comes the insurance company, also offering an incentive. Does this make the insurance company’s incentive right? Not necessarily. But to focus only on the insurance company in this equation, to express shock and horror at their incentive while ignoring the morass of promotion and persuasion used by the drug company, is to entirely ignore the full picture and the real story.

But reporting on that whole picture doesn’t make for a nice, neat, 3 minute “news” piece, does it? And what impression does a story like this leave in viewers’ minds? A PAL staffer did a presentation yesterday at a Senior housing complex, two days after the story aired, and the attendees overwhelmingly said that they had seen the report, and that they were led to believe from it that generics are not as effective – a message that was strongly implied by the story but which is a significant distortion of the truth.

(Postscript: If you’re curious about what statins are appropriate for which people, check out Consumer Reports’ Best Buy Drugs report on them)